BACKGROUND AND PURPOSE:

• van Eijk et al. (The Lancet, 2019) sought to determine menstrual cup leakage, acceptability, and safety and further assess this product from a public health perspective

METHODS:

• Systematic review and meta-analysis
• Search parameters
  • PubMed, Cochrane Library, Web of Science, Popline, Cinahl, Global Health database, Emerald, Google Scholar, Science.gov, and WorldWideScience for studies
  • Manufacturer and User Facility Device Experience database from the FDA
• Inclusion criteria
  • Quantitative or qualitative studies published in English on experiences and leakage associated with menstrual cups
  • Adverse event reports
• Primary outcome
  • Menstrual blood leakage when using a menstrual cup
• Safety outcomes
  • Serious adverse events
  • Vaginal abrasions and effects on vaginal microflora
  • Effects on the reproductive, digestive, or urinary tract
  • Safety in poor sanitary conditions
• Data analysis
  • Quality and bias assessments performed
  • Preliminary cost estimates and environmental savings vs other products currently available

RESULTS:

• 43 studies | 3319 participants
  • 15 studies were from low- or middle-income countries
  • Only 3 were moderate to high quality
  • 4 studies made a comparison between menstrual cups and usual products for the main outcome of leakage
• Reported leakage data was available in 4 studies
  • Cup compared to either usual item used (3 studies) and tampon (1 study)
  • In 3 of the studies there was no difference
  • In 1 study vs tampon, the cup performed better (p=0.041) based on Likert score data over 3 cycles (5.4 vs 4.8)
• 73% of participants wished to continue use of the menstrual cup at study completion (95% CI, 59 to 84)
• Adverse events
  • 3 women reported vaginal wounds and 2 severe pain in case reports and could not be confirmed with medical records
  • 6 reported allergies or rashes (one serious, involving silicon allergy)
  • 9 reported urinary tract complaints (3 with hydronephrosis)
• Infections were not more common among cup users vs those who used other products
  • There were no adverse effects on the vaginal flora
  • 5 reported toxic shock syndrome after use of the menstrual cup with confirmation available for only one case (streptococcus)
    • 2 cases, other relevant conditions reported (e.g., immunodeficiency)
• Dislodgement of an intrauterine device was reported in 13 women who used the menstrual cup between 1 week and 13 months of insertion of the intrauterine device
• Professional assistance to aid removal of menstrual cup was reported among 47 cervical cup users and 2 vaginal cup users (mostly via case reports)
• The authors identified 199 brands of menstrual cup and it was available in 99 countries with prices ranging US $0.72–46.72 (median $23.30)

CONCLUSION:

• Menstrual cups are a safe and effective option
• Comparative estimates of toxic shock incidence (approximate)
  • Cup: 0.8 to 3.4 per 100,000 population
  • Tampons (1980 study): 6 to 12 per 100,000 users
  • Authors note risk of toxic shock in women who use barrier methods is also quite low, however adverse events may be under-reported
• IUDs may be dislodged | Other menstrual products may need to be considered

Learn More – Primary Sources:

Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis

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